Recall Z-0198-2018 ยท JQX Nephelometer, For Clinical Use
Becton Dickinson & Co.
BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing
| Date | Jun 1, 2017 |
| Status | Terminated |
| Reason | Potential unexpected movement of robot arm |
| Root cause | Process control |
| Action | BD Diagnostic Systems telephoned all customers on June 1, 2017 and sent an Urgent Product Recall letter dated May 31, 2017, and Response Forms to their customers via email. BD recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. The issue may result in the inability of this motor to withstand the lateral forces encountered during normal operations. Should this occur, the instrument will indicate an E20 error-Pipettor step loss during operation and stop functioning. While there is no loss of patient sample, the samples would need to be manually pro |
| Quantity | 7 units |
| Distribution | Worldwide Distribution - US including CA, NC & TN Internationally: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.